Recall Z-0265-2025

Reason for recall

IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.

FDA-determined cause: Error in labeling

Action taken

The recalling firm issued letters dated August 28, 2024, which were issued 9/5/2024 via email and first class mail. The letter describes the issue, impact, and actions that should be taken. The consignee is to retain a copy of the letter as it serves as current labeling regarding biotin interference with the Access Thyroglobulin Antibody II assay. Appendix A of the letter provides the incorrect and correct sections of the IFUs. The recalling firm recommends sharing the content of the letter with their laboratory and/or medical director to assess the need for retesting. The letter informs the consignee that Beckman Coulter will update the IFUs to contain accurate biotin interference claims for the assay. Notifications will be sent when the updated IFU is available for download from the Beckman Coulter website. The letter also reports that IFU part number A38168 has been retired and will not be updated. If the affected product has been forwarded to another laboratory, the consignee is requested to provide them a copy of the letter. The consignee is to respond within 10 days electronically via email or manually by completing and returning the enclosed response form.